Manual pressure activated application mechanism

• US 10,080,582 B2
• Filed: 04/08/2013
• Issued: 09/25/2018
• Est. Priority Date: 04/11/2012
• Status: Active Grant

• Current Assignee: PharmaSens AG
• Original Assignee: PharmaSens AG
• Inventors: Hadvary, Paul, Tschirky, Hansjorg
• Primary Examiner(s): Hoekstra, Jeffrey G
• Assistant Examiner(s): Kolderman, Nicholas E
• Application Number:
  US14/391,410
• Publication Number:
  US 20150105691A1
• Time in Patent Office: 1,996 Days
• CPC Class Codes: A61B 10/0266 means for severing sample
• CPC Class Codes: A61B 17/3403 Needle locating or guiding means guides for suture needles A61B17/0482; guiding or tracking by nuclear magnetic resonance G01R33/285
• CPC Class Codes: A61B 17/3415 for introducing tubes or catheters, e.g. gastrostomy tubes, drain catheters A61B17/3417 takes precedence; body piercing catheter guide needles A61M25/06
• CPC Class Codes: A61B 17/3496 Protecting sleeves or inner probes; Retractable tips for protecting body piercing guide needles A61M25/0612
• CPC Class Codes: A61B 2010/0208 Biopsy devices with actuators, e.g. with triggered spring mechanisms
• CPC Class Codes: A61B 2017/3407 including a base for support on the body
• CPC Class Codes: A61B 2017/3409 including needle or instrument drives
• CPC Class Codes: A61M 2005/14252 with needle insertion means
• CPC Class Codes: A61M 2005/1585 Needle inserters
• CPC Class Codes: A61M 2005/1586 Holding accessories for holding infusion needles on the body holding devices for catheters A61M25/02
• CPC Class Codes: A61M 2005/1587 suitable for being connected to an infusion line after insertion into a patient
• CPC Class Codes: A61M 5/14248 of the skin patch type
• CPC Class Codes: A61M 5/158 Needles for infusions; Accessories therefor, e.g. for inserting infusion needles, or for holding them on the body

Abstract

A skin insertion mechanism includes a needle fixedly positioned in a needle holder with a connector (or connective means) to an injection or analysis system having a skin attachment plate coated with an adhesive layer and a spacer mechanism kept in the ready-to-use position, the skin attachment plate is spaced away from a needle support covering the needle. Subcutaneous insertion of the needle is effected by attachment of the adhesive layer to the skin and releasing the spacer mechanism by applying a pre-set trigger point pressure against the skin.

Claims

1. A skin insertion mechanism of a needle fixedly positioned in a needle holder and the skin insertion mechanism having a connector to an injection or analysis system, comprising:

a) a skin attachment plate coated with an adhesive layer for attachment to a patient'"'"'s skin and having a hole allowing the passage of the needle;

b) a spacer mechanism connected to and guiding an axial movement of the needle holder and the skin attachment plate relative to each other, the spacer mechanism comprising

a withholder structure releasably connected to the needle holder and the skin attachment plate and keeping the needle holder and the skin attachment plate in a ready-to-use position axially fixedly spaced away from each other to cover the needle, and the withholder structure axially moving in a direction relative to the needle holder when released, and

a coupling element keeping the needle holder and the withholder structure in the axial position by releasable connecting elements requiring a pre-set trigger point pressure to be released, and the coupling element axially moving in a direction of the axial movement of the needle holder when released; and

c) a release element movably linked to the spacer mechanism and provided with pressure exerting elements producing pressure onto the connecting elements by axial movement towards the needle holder to release the withholder structure from the ready-to-use position, and allowing the axial movement of the needle holder towards the skin attachment plate with sufficient velocity to pierce the skin by the needle and inserting the needle into the skin.

2. The skin insertion mechanism according to claim 1, further comprising a structure to exert pressure onto an outer rim of the adhesive layer extending beyond the skin attachment plate.

3. The skin insertion mechanism according to claim 2, wherein the structure to exert pressure onto the outer rim of the adhesive layer is a functional package with a rim pressing the adhesive layer towards the skin and protecting the release element against unintended activation.

4. The skin insertion mechanism according to claim 2, wherein a structure to firmly attach the outer rim of the adhesive layer to the skin is the skin attachment plate to which the adhesive surface for attachment to the skin is fixed by a reduced surface in comparison to the adhesive surface attached to the skin.

5. The skin insertion mechanism according to claim 1, further comprising a structure to couple the skin attachment plate with the needle holder and decouple from the spacer mechanism and the release element, and performing these functions automatically upon stacking-up of the needle holder and the skin attachment plate and allowing removal of the spacer mechanism together with the release element.

6. The skin insertion mechanism according to claim 5, wherein the structure to couple the skin attachment plate with the needle holder and decouple from the spacer mechanism and the release element includes hook-type elements actuated by the axial movement of the needle holder towards the skin attachment plate.

7. The skin insertion mechanism according to claim 1, wherein the needle is a cannula for subcutaneous delivery of injection fluid.

8. The skin insertion mechanism according to claim 1, wherein the needle is a plastic tube with a removable inner mandrin for insertion into the skin, the mandrin being removed together with the spacer mechanism and the release element.

9. The skin insertion mechanism according to claim 1, wherein the needle holder with the fixedly positioned needle and the connector to the injection system are separated in the ready-to-use position and get functionally connected only following needle insertion into the skin by consecutive stacking-up, first of the skin attachment plate with the needle holder, followed by stacking-up of the needle holder with the connector.

10. The skin insertion mechanism according to claim 9, further comprising a structure to couple the needle holder, the connector to the injection system, and the release element together, and performing these functions automatically upon stacking-up of the skin attachment plate, the needle holder and the connector to the injection system with the release element and allowing removal from the skin by pulling away from the skin as a unit, with the skin attachment plate being pulled by the adhesive layer attached to the skin and becoming fixed in a pulled-out position as needle protection.

11. The skin insertion mechanism according to claim 1, wherein the needle is a diagnostic probe.

12. The skin insertion mechanism according to claim 1, wherein the needle is a removable guide needle for insertion of a flexible cannula or diagnostic probe into the skin, the guide needle being removed together with the spacer mechanism and release element.

13. A method for injection of a fluid into the skin or determining analyte concentrations in a subcutaneous tissue by the steps of:

a) attaching the skin insertion mechanism according to claim 1 to the skin of a subject,

b) pressing the skin insertion mechanism against the skin by pressing on the release element with the pre-set trigger-point pressure,

c) removing the spacer mechanism together with the release element, and

d) connecting the needle to the injection or analysis system.

14. A method for injection of a fluid into the skin by the steps of:

a) attaching the skin insertion mechanism according to claim 1 to the skin of a subject,

b) pressing the skin insertion mechanism against the skin by pressing on the release element with the preset trigger-point pressure,

c) introducing the fluid into the skin with a syringe-type fluid delivery system, and

d) removing the skin insertion mechanism by pulling away from the skin.